510(k) · Cleared
ClearedStimlab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micropace Pty, Ltd. · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cleared on Oct 26, 2007 as substantially equivalent to K011826 (Micropace Pty, Ltd., 2002) after a 79-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Oct 26, 2007
- Review
- 79 days
- Class
- Class II
- Product code
- JOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854196 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK854196 Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 1986
- 1 generation backK011826 EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002
- This deviceK072200 StimlabMicropace Pty, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK173439 Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K173439Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854196 | Dci Model EP-2 Clinical Stimulator | Digital Cardiovascular Instruments, Inc. | 1986 | — |
| −1 | K011826 | EPS320 Cardiac Stimulator | Micropace Pty, Ltd. | 2002 | — |
| 0 (this device) | K072200 | Stimlab | Micropace Pty, Ltd. | 2007 | — |
| +1 | K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011826 | EPS320 Cardiac StimulatorSummary page 1…tachyarrhythmias, refractory measurements and measurements of electrical conduction. This is the same intended use as previously cleared for the EPS320, K01 1826. Predicate Device The predicate devices is the Micropace EPS320 Cardiac Stimulator - K01 1826, 24 Jan 2002 Device Descrip… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173439 (Fischer Medical, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011826.
How does its category compare?
All JOQ devicesJOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JOQ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JOQ
Too few JOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOQ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOQ
5in 2025
MAUDE reports naming product code JOQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StimLab Cardiac stimulator is intended to be used for diagnostic electrical stimulation of
the heart for the purpose of initiation and termination of tachyarrhythmias, refractory
measurements and measurements of electrical conduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072200: Stimlab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072200
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026